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Four Things All Class I Manufacturers Must Do by May 26

Medical Devices, ,

Class I devices are the lowest risk medical devices. However, the manufacturers of these devices also need to act immediately to comply with the new European Union (EU) Medical Devices Regulation (MDR); otherwise, they risk being unable to place their devices on the EU market after May 26, 2021.

As many Class I devices are being up classified, the manufacturers of these devices will require notified body (NB) review for the first time to comply with the EU MDR. Manufacturers will be relieved to know that these devices have been given a grace period till May 26, 2024. Current Class I devices may also move to Class I reusable surgical instruments (Ir), which is a newly added subclassification in MDR 2017/745. Other Class I devices such as devices with measuring function (Im), or Class I sterile (Is) devices, which have a valid MDD certificate, can be sold in the EU market till May 25, 2024. However, if manufacturers of these Class I devices do not act now, they may not know if their devices need to be re-classified. For the rest of the Class I devices, as well as for Class Is/Im devices requiring a new certificate, the timeline to comply with the new regulation remains May 26, 2021.

Through this blog, we would like to highlight the key requirements for Class I device manufacturers to place their devices on the market as per the recent EU Regulation 2017.

Checklist items for placing Class I medical devices on the market:

As most of the Class I device manufacturers self-certify their devices, it is unlikely to have a relevant quality management system (QMS) or clinical data available with them. Hence, they may require significant remediation work before May 26.

To comply with the EU MDR, Class I device manufacturers must establish and implement a risk management system to reduce risks as far as possible without adversely affecting the benefit-risk ratio.

Involvement of the Notified Body (NB)

The NB needs to be involved for Class Is, Class Im, or Class Ir devices. As per Annex IX, the manufacturer of such a device must establish, document, and implement a QMS. Additionally, with respect to Annex II, the manufacturer must lodge with the NB an application for assessment of technical documentation relating to the device. However, the involvement of the NB in those procedures shall be limited:

  • in the case of 1s devices, to the aspects relating to establishing, securing and maintaining sterile conditions;
  • in the case of 1m devices, to the aspects relating to the conformity of the devices with the metrological requirements;
  • in the case of 1r devices, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance, and functional testing and the related instructions for use.

Intervention by NB is not required for other Class I devices. As the QMS system remains proportionate to the risk class, the requirement is less complex for Class I manufacturers, but they need to meet the QMS requirements set out in Article 10 of the EU MDR. As per this article, Class I manufacturers must provide the required technical documentation in an official Union language dictated by the concerned Member State when requested by the Competent Authority (CA).

EU Declaration of Conformity

Manufacturers of other Class I devices can continue to self-certify. According to Article 19, the EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. However, manufacturers of these devices will need to update technical documentation (set out in Annexes II and III) by May 26, 2021.

CE-marking

Manufacturers of Class I devices will have to gather all relevant clinical information, especially for devices that are self-certified under MDD. This will apply to even those manufacturers whose Class I devices have been on the market for 20+ years. Manufacturers can either use already available post-market data or perform a post-market clinical follow-up study (PMCF) to provide clinical information in technical documents (set out in Annexes II & III). Hence, manufacturers of those Class I devices that have got a grace period till May 26, 2024, should not wait till the last day. They should make a robust system now to start collecting clinical data.

Post-market surveillance (PMS)

  1. Class I device manufacturers need to establish and maintain a post-market surveillance (PMS) system, which should be integrated into the QMS. According to Article 83, manufacturers shall plan, establish, document, implement, maintain, and update a PMS system for every device.
  2. The PMS plan of the manufacturer must include PMCF plan or a justification why PMCF is not applicable.
  3. Reporting time frames have been tightened in the EU MDR. As per article 87, a serious public health issue should be reported within two days. Whereas, in the event of death or an unanticipated serious deterioration in a person’s state of health, the report should be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days. For all other cases apart from the above two, the manufacturer must report any serious incident immediately and not later than 15 days, which was 30 days earlier as per MDD.
  4. As a follow-up of reporting a serious incident, the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned (Article 89).
  5. Finally, all Class I device manufacturers are expected to prepare a PMS report (Article 85) summarizing the results and conclusions of the analysis of all the data from the market. This report will be updated when necessary, for example, when the intended benefits are not achieved or when there is a change in the benefit-risk balance. The report can be requested by the CA at any time from May 26, 2021, irrespective of the type of Class I device (with or without grace period).
  6. If PMS data analysis provides evidence that a device placed on the market is not in conformity with the MDR, the manufacturer is obliged to take the immediate necessary corrective action, which can be either bringing that device to conformity, or withdraw it, or recall it.

Conclusion

Class I device manufacturers need to take immediate action to comply with EU MDR. If manufacturer’s Class I device (exception: Is, Ir, Im) was self-certified under MDD, then it must be compliant under EU MDR by May 26, 2021. If the device has been up classified as per EU MDR, certification from NB will be required to place the device on the market. Manufacturers need to gather all relevant clinical information through PMS activities and PMCF studies for devices which are self-certified under MDD to achieve CE marking under EU MDR before May 26, 2021. A QMS must be established which will include documentation of PMSP and PMSR for all Class I devices by May 26, 2021. For devices, reclassified as class Ir, and the devices already placed on the market in accordance with the MDD (Is and Im), the manufacturers have got a grace-period of three more years to fully comply with the new EU regulation. These manufacturers should start conducting a gap analysis to guarantee that all the necessary requirements are fully completed at the date of the application of MDR. Non-conforming devices will no longer be allowed to be on the EU market.

Narcolepsy – a revelation

Health & Fitness, , , , , ,

There is a time for many words there is also time for sleep – Homer

Introduction

Sleep is an important part of our day-to-day life and everybody long for a good night’s sleep after a day’s work. But do you know why you sleep at night and are awake during daytime? Do you know we have a biological clock inside us? Do you know why some people fall asleep while talking or even while driving? If you want to know the answers to these questions, please read on.

Before delving into this topic, let us first discuss the sleep-wake cycle. In a day, most people are awake for 16 hours and asleep for 8 hours on average. This sleep-wake cycle is controlled primarily by parts of the brain called the brain stem and the hypothalamus. While the precise mechanisms of control are not fully understood, researchers have found out the various biochemical and physiological changes that take place in our brain during sleep.

Arousal signals in the form of neurotransmitters are sent from the brain stem and the hypothalamus to the cerebral cortex, which is the largest part of the brain. Neurons in specific regions of the cerebral cortex are activated by the neurotransmitters. Hypocretin, also known as orexin, is an example of such a neurotransmitter.

Apart from this mechanism, sleep and wakefulness are also regulated by our biological clock – a region of the brain comprising ~50000 neurons in the suprachiasmatic nucleus. This clock is activated by light signals from the eye and received through the optic nerve. So, we can sleep during the night as there is less light and this clock will also send powerful alerting signals to wake us up in the morning.

There are several sleep disorders which can present as either excessive sleepiness (hypersomnia) or lack of sleep (insomnia).

With this background knowledge, let me introduce you to the topic of narcolepsy.

What is narcolepsy?

Narcolepsy (narke – numbness lepsis – attack) belongs to a group of sleep disorders and is characterized by excessive and persistent sleepiness. It was not recognized till the French physician Jean-Baptiste Edouard Gelineau identified and named this condition in 1880.With the research happened in the field of sleep disorders now we have a better understanding of the brain changes leading to the manifestation of this condition. 

Narcolepsy is a neurological disorder that causes sudden, recurring, and uncontrollable urge to sleep during day time. It is an underdiagnosed condition which affects 3 million people worldwide. Both males and females are affected equally. It commonly starts in teenage and early 20s but can also affect children and older people.

The exact cause of this condition is unknown. However, scientists have discovered a link between the levels of hypocretin and narcolepsy .Hypocretin is a regulator of wakefulness as it increases activity of target neurons which release epinephrine, serotonin, and dopamine and hence involved in alertness. The hypothalamic neurons which produce hypocretin are destroyed by

     a) an autoimmune process

     b) infectious agents like streptococcus or influenza virus.

     c) head injury

     d) genetic defect

It is underdiagnosed due to unfamiliarity of the physicians with this condition and sometimes takes 10 years or more before the patient receives a correct diagnosis. Affected people are often mislabelled as simply lazy, depressed, epileptic, or schizophrenic.

Symptoms of narcolepsy

There are numerous ways in which this disorder presents itself and the severity also varies. The most common complaint is of course excessive daytime sleepiness (EDS).Narcoleptics can be likened to “Sleepy,” the famous Disney character in the fairy tale of Snow White and the seven dwarfs .Those affected may find it difficult to stay awake like him during day time and will fall asleep during routine activities like talking, driving, working etc. It will be more like a “sleep attack.”

Teachers may complain to parents that their child sleeps during the class. Narcolepsy can also present as hyperactivity, irritability, memory problems and brain fog.

The excessive sleepiness may also be associated with another neurological condition called cataplexy which leads to sudden loss of muscle tone or paralysis in the form of knee buckling, head dropping or collapsing, often triggered by strong emotions or excitement.

Thus, we can categorize narcolepsy into two types

Type 1– Narcolepsy with cataplexy

Type 2 – Narcolepsy without cataplexy

Symptoms of cataplexy can precede EDS and hence narcolepsy can be misdiagnosed as a seizure disorder.

Another important feature of narcolepsy is inadequate quality of sleep at night which is often referred to as fragmented sleep. Night time sleep will be interrupted several times and the person will often feel tired after sleeping.

At times, narcolepsy can coexist with sleep paralysis or hypnagogic hallucinations (vivid dream-like events). A brief inability to move the body or speak while falling asleep or waking up is called sleep paralysis.

 Fortunately, only ~25% of affected individuals will display the full set of symptoms. All these disabilities can negatively impact education, professional life, relationships, and even personal safety of affected individuals.

How is this condition diagnosed?

Because of the varied and nonspecific presentation, it may take several years for someone with narcolepsy to get diagnosed properly. Hence the treating physician need to take a detailed history and conduct a thorough medical examination.

The doctor will ask the patient to keep a sleep journal to record the time of sleep, symptoms experienced etc over a period of 2 weeks. Sleep specialists have devised two tests viz; Polysomnography (PSG) and Multiple Sleep Latency test to establish the diagnosis of narcolepsy.

Polysomnogram (sleep study) is a recording of breathing, eye movements and activity of brain and muscles during night.

Multiple sleep latency test – this test helps to determine how quickly a person falls asleep during day time.

How can it be managed?

Narcolepsy is a disease which can persist throughout life as there is no cure. However, symptoms can be successfully controlled by lifestyle changes and medications. Medicines like modafinil, antidepressants, and stimulants are the main stay of drug therapy. But medication alone will not be sufficient to maintain a normal state of alertness.

Patients need to be taught proper sleep hygiene to maintain a regular sleep schedule. Several support groups are available to help patients develop coping strategies and to offer emotional support. Even though it is an incurable disease, the advancements in the management of narcolepsy have enabled people to lead near normal life.

Points to remember!

  1. Narcolepsy is a sleep disorder which is characterized by excessive day time sleepiness.

2. It is caused by lack of a neurotransmitter called hypocretin in the brain.

3. It usually starts in teenage and early twenties.

4. It can be associated with another neurological problem called cataplexy.

5. It is often misdiagnosed and it might take several years for the affected person to get a proper diagnosis.

6. It is an incurable disease but affected people can lead a normal life by taking medicines and by following life style changes.

Pain and Recent Advances in Managing Pain

Health & Fitness, , , , , ,

What is pain?

Pain can be a displeasing and uncomfortable experience associated with possible damage to the body. The word ‘pain’ is derived from Latin literature, ‘poena’ meaning penalty or punishment. The majority describe it as an irritating, overwhelming, unpleasant, and terrible phase to go through. Most of us can recall visiting a medical chamber with different kinds of pain.

Let us dwell deeper into pain, based on time, intensity, location, and types.

  1. Duration of time:

Pain can be acute or chronic.

Acute – It is sudden, momentary, or a short period of fewer than 3 months.

Example- Pinprick, minor injuries

Chronic – It usually lasts longer than 3 months and more resistant to medical treatment with time.

Example- Arthritic pain, migraines

2. Intensity:

The feeling of pain can be mild, moderate, and severe measured on a pain scale of 0-10.

Although, the perception of intensity may differ among individuals. Severe pain for one felt as moderate by another.

Example- Minor fall from the cycle, major brain trauma

3. Location:

It can differ in locations. It can be anywhere from top to toe.

Ex- Back pain, knee pain, stomach pain

4. Types:

Pain can be superficial, deep, or psychogenic.

Superficial – Direct irritation (chemical/ mechanical/thermal/electrical) of the peripheral nerve endings in the superficial tissue.

Deep – Due to irritation of deep structures like the muscles, the tendons, the bones, the joints, and the viscera.

Psychogenic – Pain attributed to the processing of thoughts, mental and emotional state, or other unknown behavioral causes.

Can the tip of my shoulder be hurting? What else could be the reason for my pain?

So, let us discuss a bit more about pain and then go into how one can free themselves from pain and tips to manage pain!

Pain can be originating elsewhere and felt elsewhere. Pain can radiate, refer, or migrate! Your pain can travel and move around! How is that possible? Through the brilliantly intricate nervous system, we possess!

Our body is unique in a way that no one can decipher it to 100%.

Not just yet!

The central role of controlling and managing pain is to release the stress and suffering associated with it on an everyday basis. Sometimes, pain can be extremely distressing, leading to mental disturbances in the long term. It can lead to anxiety, depression, loneliness, debilitating one’s life to the extreme side.

Therefore, it is wise to act and take control.

The evidence-based management of pain

Management of pain can be abled by using modern medicine or traditional techniques like acupuncture, homeopathy, physiotherapy, massage, yoga, meditation, physical therapies, psychological therapies, occupational therapies, etc.

On an individual level, leading an active lifestyle, changing to a nutritious diet and food, physical activity for 20 minutes a day 4-5 times a week can lead to an overall increase in quality of life and alertness levels of the body.

For minor injuries or falls, menstrual cycle pains, headaches, causing mild pain, the first reach out is the first aid kit, OTC (over the counter) drugs like paracetamol, aspirin, ibuprofen, and some prescribed antibiotics and topical ointments if infection presents.

How much freedom does a pharmaceutical drug intervention bring? That depends on the type of pain; chronic pains usually do not subside on taking drugs but need a combination of therapies.

Acute and sudden pain conditions can sometimes be fatal requiring urgent medical care and surgical treatment. For example, appendicitis, obstructed bile duct, acute pancreatitis, kidney stones, heart attack, head injuries, trauma, etc.

Chronic conditions eventually become resistant to the regular drugs and need stronger management pain regimes.

For example, arthritic knee joint pain, lower back pain due to slip disc or compression of nerves, nerve conditions like sciatica or neuralgias, cancer pains, constant headaches due to migraine, tension headaches, post-surgical pain, structural deformities like scoliosis & lordosis, psychogenic pain, etc.

Drug treatment – Analgesics or pain relievers like aspirin, Ibuprofen, Naproxen is usually the first-line treatment for mild to moderate chronic conditions.

Opioids are the last reserve when the pain is resistant and non-responsive to other lines of treatment.

OTC creams and ointments like lidocaine can be applied topically for relief 2-3 times a day or as told by the physician.

Anticonvulsants and nerve supplements are used to treat multiple chronic nerve conditions like injuries and diabetic neuropathy.

A newer class of drug under investigation is the monoclonal antibodies, which target the nerve growth factor (NGF), a peptide involved in the growth and survival of neurons that regulate how the body processes pain.

Nonpharmacological management

  • Mild exercise improves blood circulation and reduces mild to moderate pain. (Caution – Heart condition, Disability)
  • Physiotherapy is a new line of pain management with many advances for musculoskeletal disorders, nerve conditions causing chronic pain.
  • Physical heat/cold therapy – Icing and hot packs
  • Acupuncture, meditation, massages, aromatherapy, yoga are some other personal preferences of many.

Psychogenic pain- Mental well-being and counseling – Seeking psychiatric care for mental illness is the right of the brain, body, and well-being of the person in society.

Cognitive-behavioral therapy – Coping mechanisms and stress reduction techniques among the wide range of CBT methods

Antidepressants – Avoid self-medication and always seek professional help.

Genetic modeling is a newer science, which can strike a great deal in the way we perceive and manage pain. Science is all about optimism. Epigenetics, modification of gene expression, examples – like a fan switch or a remote button.

Neuroplasticity – the ability of the brain and spinal cord to adjust their activities in response to new changes.  For example – To compensate for injury and pain

Seeking professional medical care should be the first step for any kind of pain for assessment and evaluation.

However, one can do a self-assessment with the PQRST characteristics, Pain rating measurement scale ranging from 0 – 10, and quality of life.

  • P   Provocative factors: what intensifies the pain?
  • Q   Quality of pain: what kind of pain is it?
  • R   Radiation of pain: Is it at the same location or moving?
  • S   Severity of pain: how does it feel?
  • T   Temporal factors: Is the pain universal or comes and goes away?

One can take an informed decision and visit the nearest health center or pain clinic for the best care and treatment.

*Keep in mind the hazards associated with self-medication and combination of drugs without the right professional help*

Staying fit while working from home

Health & Fitness, , , ,

Working from home comes with its own set of pros and cons. And staying fit while working from home is a challenge. Setting up a routine and breaking down the plan into feasible goals is all that is required.

Key points to stay fit while you work from home

  • Setting up a routine
  • Creating a workspace at home
  • Healthy eating habits
  • Adequate sleep
  • Physical activity
  • Mental health
  • Social interactions
  • Positive attitude and empathy

Setting up a routine

  • Start your day with a morning routine that includes yoga, jogging, or any physical activity. Make sure you keep aside a few minutes to plan your day.
  • Make plans so that you don’t mix up work and family time. Focussing on one thing will bring out the best in you.

Creating a workspace at home

  1. Create a quiet, well-lit workspace.
  2. A clutter-free desk with minimal things will reduce chaos and help you work effectively.
  3. Watch your posture while sitting on a chair.
  • Adjust the chair to support your back and arm.
  • Let your feet lie flat on the floor.
  • Maintaining the curve of the lower back (upper lordotic sitting) is one of the optimal position recommended by the physiotherapists.1

4. Computer vision syndrome is a group of symptoms that you experience when you sit in front of the computer monitor for a prolonged time in the same position.

Key points :

  • The monitor should be at the level of your eyes.
  • Keep the monitor at a distance of 53 to 72 cm from the eyes.2
  • Ideal positioning will reduce your neck discomfort.
  •  Use filters to reduce the screen glare.
  • Keep your eye moist by blinking frequently.
  • Take breaks while viewing the monitor and give your eyes some rest.
  • 20-20-20 rule: take a break once every 20 minutes and view things 20 feet away for 20 seconds.
  • You may have to change your eyeglasses or contact lenses if you are having discomfort.
  • Consult your doctor if the symptoms persist, and also schedule regular eye examinations.

Healthy eating habits

  1. Take frequent breaks from work to drink water (10-12 glasses in a day).
  2. Replace your fries, cookies, and muffins with fruit, nuts, and vegetables.
  • Healthy snacks bring down the calorie and have lots of benefits.
  • According to the Centre for Disease Control and Prevention (CDC), only 1 in 10 individuals consume enough fruits and vegetables in a day.
  • Fruits and vegetables help to protect you from heart disease, stroke, cancer, and overweight.3

3. Practice mindfuleating

  • Eat your meals slowly and enjoy the food; stay away from the distractions like television, phone, and so on
  • Mindful eating will help digestion and curb overeating.
  • Try eating mindfully at least once a day; it will benefit you in the long run.

4. Limit caffeine consumption in your diet

  • Coffee, tea, caffeinated soda, and energy drinks contain caffeine.
  • You should avoid replacing plain drinking water with caffeinated drinks.
  • Though caffeinated beverages are relatively safe, they can get addictive at times.
  • Too much caffeine may lead to insomnia, restlessness, digestive problems, high sugar level, and diuretic effect causing dehydration.4
  • Hence consume caffeine in moderation and always wean gradually from the habit.

5. Vitamin D

  • You may be lacking the sunshine vitamin; hence, make efforts to get the rays by keeping the windows open or taking a stroll on the balcony.
  • Include food rich in vitamin D such as milk, egg yolk, cod liver oil, and fortified grains in your diet.
  • Vitamin D is required for your bones’ growth and health; It is vital for the immune system that protects you from infections.

Sleep

  1. Adequate sleep has a lot of benefits.
  2. Sleeping well at night will help you focus and concentrate better; it affects your judgment and reaction time.
  3. Sleeping between 7-9 hours is ideal for you, and the duration varies depending on age.
  4. According to a study, people having around 7 hours of sleep/night are at a lower risk of developing overweight, hypertension, and diabetes (metabolic syndromes).5

Physical activity

Physical includes a spectrum of activities like exercise, household chores, and leisure activities; It improves your life quality. They have immediate and long-term benefits.

Benefits of exercise

  1. Regular exercise offers multiple health benefits.
  2. Exercise plays a significant role in treating obesity, lung disease, heart disease, diabetes, cancer, and low back pain.
  3. Recent studies suggest that exercise reduces your risk of developing long-term (chronic) health conditions like high blood pressure, diabetes, heart attacks, and stroke.
  4. Regular exercise will strengthen your bones and muscles; It helps you manage weight and reduce arthritis.
  5. According to recent physical activity guidelines, you can attain substantial health benefits by engaging in physical activity for 150 minutes a week.
  6. When you exercise, the body releases endorphins (feel-good hormones). Endorphins boost happiness; hence, they reduce stress and calms down your mind. You can sleep better too.

Mental health

Mental health is as important as physical health; It includes emotional, psychological, and social well-being. Mental health is all about how you handle the highs and lows; make choices, and keep calm amidst the chaos.

Yoga

  • Long-term stress and anxiety may increase the risk of developing heart disease, diabetes, cancer, and inflammatory conditions.
  • Studies have shown that yoga reduces stress hormone levels called cortisol (downregulation of hypothalamic-pituitary-adrenal axis) in your body; hence, it can ease stress and anxiety.
  • Yoga also has a beneficial effect on depression. It acts as an antidepressant.6
  • Practicing yoga as a routine will calm your nerves and bring peace of mind.
  • Pranayama includes breathing exercises. It offers a lot of health benefits, both physical and mental.
  • Practice yoga for a healthy body and mind.

Nurturing a hobby

  • Nurturing a hobby is very satisfying; it is right for your mental health.
  • It includes reading a book, gardening, dancing, games, and so on.
  • A hobby can lower stress levels and enrich your life.

Social interaction

  • Working from home shouldn’t limit your social life.
  • Spend quality time with your family and friends.
  • Make plans with your friends and meet them often.
  • Volunteering for a specific cause you believe in will create an opportunity to meet people and add value to your life.

Positive attitude

Being positive, grateful, and empathetic will impact your overall well-being.

Conclusion

Most of us are aware of all the steps mentioned to stay fit while working from home, but we still procrastinate. The best way to start is to set small achievable goals and gradually build them up. It’s never too late to make positive lifestyle changes. Stay fit, stay happy!

References:

  1. Korakakis V, O’Sullivan K, O’Sullivan PB, et al. Physiotherapist perceptions of optimal sitting and standing posture. Musculoskelet Sci Pract. 2019;39:24-31. doi:10.1016/j.msksp.2018.11.004
  2. Rempel D, Willms K, Anshel J, Jaschinski W, Sheedy J. The Effects of Visual Display Distance on Eye Accommodation, Head Posture, and Vision and Neck Symptoms. Hum Factors. 2007;49(5):830-838. doi:10.1518/001872007X230208
  3. CDC. Steps to Safe and Healthy Fruits & Vegetables. Centers for Disease Control and Prevention. Published December 10, 2020. Accessed December 15, 2020. https://www.cdc.gov/foodsafety/communication/steps-healthy-fruits-veggies.html
  4. Reyes CM, Cornelis MC. Caffeine in the Diet: Country-Level Consumption and Guidelines. Nutrients. 2018;10(11). doi:10.3390/nu10111772
  5. Smiley A, King D, Bidulescu A. The Association between Sleep Duration and Metabolic Syndrome: The NHANES 2013/2014. Nutrients. 2019;11(11). doi:10.3390/nu11112582
  6. Naveen GH, Varambally S, Thirthalli J, Rao M, Christopher R, Gangadhar BN. Serum cortisol and BDNF in patients with major depression-effect of yoga. Int Rev Psychiatry Abingdon Engl. 2016;28(3):273-278. doi:10.1080/09540261.2016.1175419

EUDAMED – European Database for Medical Devices

Medical Devices, , , , , , , ,

Background

According to European Commission a web-based portal EUDAMED is being developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The system consists data on medical devices that have been collected and registered by Competent Authorities and the European Commission and can only be accessed by these same parties. The amount of data which will be available to the European Authorities through EUDAMED is the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR) Article 33. This data collection with EUDAMED was established by the Medical Device Directive (MDD) Article 14a. But the amount of data made available to the European Authorities has been minimal compared to what is envisaged in the new EU MDR. This ‘MDR EUDAMED’ is intended to provide more data, of higher quality and with a wider accessibility. EUDAMED aims at improving transparency and coordination of information regarding medical devices available on the EU market.

Database Access

The ‘MDR EUDAMED’ will not only be used by the National Competent Authorities (NCAs) and the European Commission. Depending on the type of user, only certain levels of the databank can be accessed. It will also be accessed by:

  • Medical Devices Coordination Group (MDCG)
  • Notified Bodies (NBs)
  • Economic Operators (EOs – manufacturers, authorized representatives, importers, sponsors)
  • Experts
  • Non-European Competent Authorities (NCAs)
  • And the public, including medical institutions and the press

Database Module

EUDAMED will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable. EUDAMED is structured around 6 interconnected modules and a public website:

  • Actors ((NCA’s, EOs, NB’s) registration
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

One of the key objectives of the Medical Devices Regulation (MDR) is transparency aiming at providing a larger access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market. These obligations in MDR will be applicable once the EUDAMED is fully functional.

Key information accessible to the public in EUDAMED:

  • Registration of all manufacturers, their authorized representatives and importers placing medical devices on the EU market
  • Registration of devices, the core elements of the UDI database of part B of Annex VI, including the basic UDI and UDI-DI of devices
  • Registration of certificates of conformity, their scope and validity period
  • List of notified bodies designated under the MDR, their identification numbers and their conformity assessment activities through a link to NANDO database and the list of their subsidiaries
  • Scientific opinions of the expert panels and the written justification of the notified body where it has not followed the scientific opinion of the expert panel
  • Clinical investigation reports and their summary
  • The summary of safety and clinical performance reports for implantable devices and class III devices
  • Manufacturer incident reports (partial access) and the field safety notices for Vigilance activities
  • Summary of the results of market surveillance activities on their national territory by each EU Member State.

Key information publicly available outside EUDAMED

  • National measures taken by competent authorities for the placing on the market of single use devices which are reprocessed
  • Types and levels of fees levied by Member States for funding activities carried out by the competent authorities
  • National measures governing the assessment, designation, and notification of notified bodies
  • List of standard fees from notified bodies
  • Summary of each Member State report on its monitoring and on-site assessment activities regarding notified bodies
  • Commission annual summary report of the peer review activities of authorities responsible for notified bodies,
  • Declaration of interests of top-level management of notified bodies
  • Declaration of interests of each member of the MDCG, of its sub-groups except for stakeholder organizations, and of the advisors within the expert panels and expert laboratories
  • Advice provided by the expert panels
  • Names and affiliation of the members of the MDCG.

Important EUDAMED Dates

For the EU Commission this development and implementation of EUDAMED is a high priority. And with help of MDCG, it is going to release different modules as soon as they become functional. Currently the deployment of Actor registration (first module) is planned for December 2020. The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be presented as soon as they are operational. Most of the requirements on Transparency and public access to information linked to the EUDAMED, are planned to become fully functional by May 2022. The official web address of the EUDAMED public website will be “ec.europa.eu/tools/eudamed”. It will be available once it is in production and not before.

Turacoz Healthcare Solutions understands medical device regulatory MDR requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].

References

  1. https://ec.europa.eu/health/md_eudamed/overview_en
  2. https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/transparency_factsheet_en.pdf

 

PMCF Planning as per EU MDR

Clinical Trials

As the Medical Device Regulation (MDR) deadlines are approaching for re-certification and/or introduction of new products, manufacturers are also working to start or fulfil the Post-market Clinical Follow-up (PMCF) activities as per requirements set out in Annex XIV, part B of the MDR.

The Annex states “PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer’s post-market surveillance plan”.

The purpose of PMCF is:

a) to gather information regarding:

  • rare complications
  • clinical observations only seen in a larger user/patient population
  • clinical observations only seen after long-term use of the device

b)  verification of clinical risk-benefit analysis conclusions

PMCF requirements as per EU MDR

A successful PMCF plan ensures that safety and performance results are continuously available to the market. PMCF should be carried out to proactively collect and evaluate clinical data per the method laid out in the PMCF plan which aims at:

  • confirming the safety and performance throughout the product lifecycle
  • identifying risks and previously unknown side-effects while continually monitoring already identified side-effects and contraindications,
  • ensuring the continued acceptability of the benefit-risk ratio, and
  • identifying off-label uses of the device, while ensuring the intended purpose is correct in the environment it is supposed to be used.

If through PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer must implement them and update the post market surveillance report accordingly.

Therefore, PMCF plan specifies the methods and procedures that will be used to proactively collect and evaluate clinical data in relation to the product’s safety as well as clinical performance.

PMCF Planning Pitfalls

Some of the most common pitfalls in planning a prospective clinical PMCF plan are: 

a) Time-consuming ethical approval

Overall delay in planning a PMCF study might happen due to requirement of approval from ethical committees, which can be a time-consuming task as requirements may vary from country to country.

b) GDPR Compliance

The GDPR is a comprehensive regulation which can help identify the safety, performance, and risk profile specific to your device. The key to compliance lies in selecting systems that guarantee the correct security and safety measures and obtaining clear informed consent from respondents/patients. 

c) Key Opinion Leaders

It is important to collaborate with a network of key opinion leaders in the region you are seeking approval as conducting as planning a PMCF study requires correct and relevant data reported to ensure the safety and performance profile of the device is rightly captured. Clinical experts in the region can help assess and guide these requirements as they have expertise in the filed due to their exposure to working with such devices.

 

Medical Device Industry and COVID-19: Regulatory Modifications to Consider

Medical Devices, , , , , , , , , , ,

Background

The COVID-19 outbreak is a public health crisis that this generation has never seen before and has presented itself as an unprecedented challenge to the health industry including the Medical Device and Regulatory framework.

There is tremendous burden being faced by first responders and health institutions. Simultaneously, there is increasing pressure on national authorities, EU member states, and economic operators to supply vitally important medical devices at the time of adoption of Regulation (EU) 2017/745.

The unanticipated crisis has had a significant impact on placing devices on the market in the Union while halting the designated work of the notified bodies. The commission recognizes the role of Personal Protective Equipment (PPEs) such as medical gloves, surgical masks, and equipment for intensive care in the current pandemic and has therefore decided to prioritize the demands of such equipment thereby avoiding any potential market disruption.

MDR defers till 2021

Therefore, the European Commission released a proposal earlier in April to defer without any alterations to the guidelines, the enforcement of the EU Medical Devices Regulation (MDR) for a year, applicable from May 26th, 2020. However, the commission made no deferments for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022. The aim of the deferment has been to ease the pressure on the medical fraternity to be able to cope and focus with the current crisis and minimize risk to medical professionals.

National Derogation

In scenarios of a public health crisis, such as COVID-19 the Regulation (EU) 2017/745 allows the commission to extend the validity of a national derogation for a limited period of time in exceptional cases for member states in response to address Union-wide shortages of vitally important medical devices in an effective manner.

The Commission has agreed with the European standardization organization to make originally copyright standards (including EN 149 and 14683) freely and fully available by the national standardization bodies. Manufacturers can download a copy for free from the online catalogues of the national standardization bodies.

Furthermore, Directives 90/385/EEC and 93/42/EEC of the regulation empower national authorities on duly justified requests to place medical devices on the market for whom relevant conformity assessment has not been completed but substantial evidence is available to prove interest of public health, patient safety, and health.

Market approval of devices without CE marking

In exceptional circumstances, products can be placed on the market even if no CE marking has been affixed upon them, given that the following conditions are fulfilled:

  • The products manufactured are in accordance with one of the EN standards or other standards referred to in the WHO guidelines
  • The products are part of a purchase organized by the relevant Member State authorities;
  • The products are only made available for the healthcare workers;
  • The products are only made available for the duration of the current health crisis; and
  • The products are not entering the regular distribution channels and made available to other users.

This approval, may bring some relief from the intense pressure on manufacturers to complete the MDD/AIMDD work by giving them an additional year while ensuring devices reach hospitals. Meanwhile, the European parliament and the Council continue to work together to adopt the legislation as mandated implementation date.

Take home message

It is important to note and acknowledge that the framework of manufacturers, regulatory bodies, and agencies continue to work on collaborating and collectively contributing in ensuring that medical devices are used safely amongst patients in this evolving pandemic.

Turacoz Healthcare Solutions understands medical device regulatory requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].

Role of a Medical Writer in Publication Documents

Medical Writing, , , , , , , ,

Background

Writing is a medium of human communication to express one’s thinking in easily understandable but effective way. The strength of writing is displayed by its knowledge-transforming effects. Knowledge is vital at every stage of research-based endeavours in basic research, clinical research, drug development lifecycle, drug approvals, phases of clinical trials, and post-marketing research.  At each stage, this knowledge is passed on in writing to communicate the findings of research to the scientific community, clinicians, regulators as well as public.

Importance of publication

Publishing biomedical research, in the form of case reports, original articles, literature reviews etc. in peer-reviewed journals, is important. Doing so, augments understanding of health, diseases and their management, drug risks and benefits, and helps to improve medical practice benefitting the patients, health community and society at large.

Reasons to not publish

However, despite the fact that most clinicians and researchers understand the need to publish their work, this task may prove challenging to them because of various reasons including lack of time to write and submit, inadequate data analysis support and technical writing expertise, and lack of knowledge of publication practices and guidelines (1).  But, we all understand and admit that scientific information can be difficult to read and to comprehend. A poorly written information could easily confuse the reader and leave the audience misinformed. For these reasons, numerous papers are rejected by top peer-reviewed journals.

Medical Writing services

Medical writing is communication of scientific and clinical information in a clear, accurate, unbiased, and logical way to a specific set of target audiences such as clinicians, healthcare professionals, regulators, scientists, patients, and general public. This includes the preparation of different types of documents: Regulatory (e.g. clinical trial protocols, clinical study reports, investigator’s brochures, new drug applications, research proposals, informed consent documents); Publications (e.g. original articles, literature reviews, case reports, editorials, abstracts for conferences); Medical education (e.g. posters, continuing medical education (CME), e-learning modules, slide decks for meetings, brochures and internet content for physicians and patients); and Medico-marketing (e.g. literature for product promotion) (5).

Medical Writing – need and demand

There’s pressing need for effective presentation and dissemination of knowledge to accelerate publishing and decision-making in healthcare. Supporting this, a Portuguese report highlighted the importance of medical writing skills for successful publishing in top-rated journals (2). Furthermore, according to a report, global demand for medical writing market was valued at approximately USD 2.03 billion in 2018 and is expected to generate a revenue of around USD 2.95 billion by the end of 2025 (3). Even in India, the medical writing industry is on an upward growth path (4).

Medical Writer – skills and role in publication

Researchers and clinicians may be best at their jobs, but they may not necessarily have the skills to present their data in an effective manner. A medical writer (MW) is a scientific writing and editing expert with an advanced degree in biomedical sciences (e.g. MBBS, PhD) and robust understanding of biomedical and clinical research, reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT (6). He/she would possess substantial data analysis skills to be able to summarise and present even the most complex clinical research data in a coherent manner. This helps the researchers to achieve objectives such as getting their work published in a respected journal, receiving funding for research projects or finding acceptance of their work by their professional peers.

Therefore, the documents prepared with the support of medical writers are less likely to get rejected or retracted by the peer-reviewed journals as they adhere to the reporting and publication guidelines specified by the journals. Such documents are accepted for publication quickly as good writing fastens the review process as compared to the ones without any such support (7). All this suggests that a MW makes a substantial contribution towards a good quality research publication. In addition to providing writing assistance, a MW advise on the right journals for an article and offer support for editing, journal styling and submitting the manuscript for publication (Figure 1).

A MW has the ability to model his/her writing in terms of most suitable language and level of technical information depending on the target audience. For instance, the documents entitled for medical professionals usually include detailed clinical information or data while the ones intended for common people are in simple language and free of core scientific details. In regulatory writing, a MW is well aware of the prescribed formats and regulatory guidelines to be strictly followed in order to produce the high-quality documents.

MWs are not involved in the conception, design or execution of clinical research, so they are not listed as authors, but their contributions are mentioned in the acknowledgments section of the manuscript (8).

Conclusion

Clear, logical, and accurate writing reinforces the dissemination of reliable research information through good quality publications to varied target audience. MWs play an important role to speed up the publication process to meet the growing need for high-quality, timely publications. Clear understanding of the role of a medical writer in publication development will pave the way for their appropriate use by clinicians and scientists to communicate their research findings to the scientific community.

The Medical Writers at Turacoz Healthcare Solutions (THS) understand and abide by the reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT to deliver high-quality documents communicating scientific and clinical information. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

If you have any queries, email us at [email protected].

References

  1. Sharma S. Professional medical writing support: The need of the day. Perspectives in clinical research 2018; 9:111-112.
  2. Marinho RT, Donato H, Fernandez-Llimos F, Massano J, Silva JM, Almeida M, et al. Think Tank: Relatório estratégico sobre publicação científica biomédica em Portugal. Acta Med Port. 2014;27:1-3.
  3. Global Industry Perspective, Comprehensive Analysis and Forecast, 2019 – 2025. Available from: https://www.zionmarketresearch.com/report/medical-writing-market. Accessed on 15 July 2020.
  4. Shirke S. Medical writing on an accelerated path in India. Perspect Clin Res. 2015;6:125-128.
  5. Bissau J, Borrego P. Professional medical writing: A tool for high quality publications. Acta Med Port. 2015;28:545–7.
  6. Das N, Das S. Hiring a professional medical writer: is it equivalent to ghostwriting? Biochem Med. 2014;24:19-24.
  7. Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780.
  8. Angela Stocks, Donna Simcoe, Dikran Toroser & Lisa DeTora. Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications. Current Medical Research and Opinion 2018;34:1163-1168.

Working from home in pandemic: How yoga can be your best friend in this time?

Awareness Day/Month, Health & Fitness, , , , , ,

It has been weeks and months since we have stopped counting days being in this pandemic-driven lockdown. There is a unique quality to this day-by-day pandemic despair; this quarantine depression is edging humans into physical and mental stagnation.  According to an article I read in the Hindu couple of days back, approximately  12.2 crore Indians lost their jobs during the coronavirus lockdown in April 2020 only, which makes COVID 19 pandemic much more stressful for people.

Not only for people who have lost their jobs, but also for people who are working from home in this pandemic and trying to juggle between their family and work without any house help and childcare services available, that this pandemic is proving more emotionally exhausting than the virus itself. With an official Microsoft TEAMS video call in my morning joggers or stirring the ladle in a cooking pot with my official call in my earpods and with my toddler in my arms, I too am acing at juggling! Watching this situation very closely for past couple of months now, I feel a more accepting and holistic approach to this fiasco is the need of the hour.

We all know that there is uncertainty & fear and we all are multitasking around for the past 4-5 months, but instead of getting bogged down, coping with stress in a healthy way will not only make us, but the people we care about and our community stronger. The best we can do is accept the situation and take care of our and our family’s mental and physical health. One way that I discovered and loved during this period, is a 40 minutes yoga routine with 10 minutes meditation, to reinforce my strength and potential. Every single day for past three months now: believe me these are the most blissful 60 minutes I have from my day! I feel that my mind is calmer and more focussed; I am able to do one thing at a time, that too perfectly and my productivity has increased like anything. I am following a very good book ‘Light on Yoga’ by BKS Iyengar and practicing yoga from the same.

It can be anything, as long as you are present in the moment mentally & physically and moving, stretching and doing basic pranayama initially for 10 minutes in a day and gradually increasing to half an hour or 40 minutes; but please follow the same with 10 minutes of mediation (just focussing on your breath with closed eyes) and you will feel a positive change in your day. You can even take breaks in between your office calls and stretch your arms, necks or legs for 2 minutes on the chair or your yoga mat.

On the occasion of International Yoga Day 2020, I am sharing some of basic yoga poses which I have been practicing and you can also start with them as a beginner in yoga journey:

Trianga Mukha Eka Pada Paschimottanasana: Keeping one knee folded, try to touch your nose to the other stretched knee. It gives a nice and long stretch to your tense back and can make you ready for a long office call.

Matasyasana: Matasyasana or  Fish pose is a reclining back-bending pose. It relieves tension in your neck, throat, and shoulders and stretches and tones the front of your neck and your abdominals. It could be proven beneficial for all the creative people who like to keep their neck in the laptop screens for better focus.

Dhanurasana: Dhanurasana or chakrasana or wheel pose or The Upper Facing Bow whatever you can call, it can help—and strengthen your arms, legs, abdomen, and spine. For this one, you bend your knees and place your heels as close to the hips as possible and then slowly raise your arms, bend your elbows by resting the palms beside your ears.Floating camel pose: an advance version of Utraasna. This one is little bit of an advance yoga pose and maybe you will be able to do it after a month’s practice but the benefits are for sure worth the pain in the process. It increases flexibility in the spine, stimulates the nervous system, opens the chest and shoulders, improves circulation and digestion, and stimulates the thyroid gland. It’s said to rejuvenate/increase energy levels, and lower blood pressure.Sirsasana or headstand: and finally the king of all the yoga poses, The headstand. This is definitely a very advance yoga pose but is known as the most relaxing and cooling posture. It helps you to draw your attention inwards, to concentrate more, to focus more. This posture is extremely helpful if you are having anxiety, stress, fear or otherwise worrisome thoughts. Combine headstand with long, slow breathing and you have a recipe for stress relief.

So happy International yoga day 2020 people and I would like to leave you with a very special quote from my favourite yogi BKS Iyengar, ‘Yoga is a light, which once lit, will never dim. The better your practice, the brighter the flame.’

Good Clinical Practice Guidelines by WHO

Clinical Trials, , , ,

Good Clinical Research Practice (GCP) is an established international ethical and scientific quality standard process for the design, conduct, performance, auditing, monitoring, recording, analysis, and reporting of clinical studies. GCP ensures that the reported data and results are credible and accurate, and the rights integrity and confidentiality of study subjects are respected and protected. All the stakeholders must adhere to the GCP standards including research subjects, sponsors, investigators, contract research organizations (CROs), site staff, ethics committees, and regulatory authorities.

Goals of Good Clinical Practice

The GCP is established with the following aims:

  • To protect the rights,safety, and wellbeing of humans involved in research
  • To assure the accuracy, reliability, quality and integrity of data collected
  • To provide standards and guidelines for a well-conducted clinical research
  • To speed up the marketing and promotion of new products
  • To ensure benefit to both sponsors and consumers by reducing the cost of trial and investigation products.

Figure 1: Goals of GCP

Compliance of GCP assures public that the safety,rights and well-being of human subjects involved in research are protected and are consistent with the principles stated in the Declaration of Helsinki and other internationally recognized ethical guidelines.

Foundations for Ethical Conduct

Declaration of Helsinki

Declaration of Helsinki (1964) was developed as a statement of ethical principles to guide physicians and other participants in medical research involving human subjects.

The other foundations for the ethical conduct of clinical research include:

  • The Nuremberg Code (1947): After the second world war, Nuremberg trials of war criminals resulted into introduction of 10 elements of medical ethics, known as ‘Nuremberg Code’, in August 1947, to protect human subjects from cruelty and exploitation while conducting human experiments.
  • The Belmont Report (1979): As a result of National Research Act of 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research had written ‘The Belmont Report’. It was created to identify the basic ethical principles for the conduct of biomedical and behavioral research involving humans and develop guidelines to make sure that the research is conducted in accordance with the principles.
  • International Conference on Harmonization (ICH-GCP): ICH provided the international quality standard to harmonize technical procedures and standards, enhance quality and accelerate time to market.
  • International Standards Organization (ISO): ISO 14155:2011 developed international standards to protect the rights, wellbeing and safety of human subjects, ensure the accuracy and reliability of results, define the responsibilities of sponsorsand clinical investigators, and assist sponsors, investigators, regulatory authorities, ethics committees, and others involved in the conformity assessment of medical devices.
  • Code of Federal Regulations (CFR): CFR is the codification rules and regulations published in the Federal Register by the federal government of the United States. The CFR includes FDA regulations on human subject protection and the conduct of clinical studies.

Background

WHO organized a ‘Scientific Group on Principles for Clinical Evaluation of Drugs’ in 1968 and then in 1975 to review and formulate principles and guidelines for clinical evaluation of drugs, new indications or dosage forms for marketed drug products and new combination products, and covering all aspects of drug development.In 1995,the WHO published ‘Guidelines for good clinical practice for trials on pharmaceutical products’ based on these reports.

WHO Principles of GCP

There are 14 principles of WHO GCP and are summarized as follows:

Principle 1 –Ethical Conduct: All clinical trials must adhere to basic ethical principles which have their origin in the Declaration of Helsinki, namely equal importance for persons, beneficence, and justice, permeate all other GCP principles.

Principle 2 –Protocol: A detailed, clear protocol including background, rationale, objective(s), design, methodology, statistical considerations, information, and organization of a trial should be laid out for every clinical research involving human subjects and comply with scientific standards.

Principle 3 – Risk Identification: Beforea study/trial is initiated, all foreseeable inconveniences and risks should be assessed against the estimated benefit(s)for the individual trial subject and society. A proposed clinical trial should be supported by sufficient non-clinical and clinical information for source of information, knowledge of literature, and on adequate lab, and where applicable, animal experimentation.

Principle 4: Benefit-Risk Assessment: Trial with human subjects should be initiated and continued only if the predicted benefits outweigh the risks for the individual and society. The safety and well being of the trial subjects should be considered most important over the interest of science and society.

Principle 5 – Review By IEC/IRB:A protocol review of a clinical trial involving humans,should be submitted for consideration, guidance, evaluation, comments, and approval by specially appointed independent ethics committee/institutional review board (IEC/IRB).

Principle 6 – Protocol Compliance: Research with humans should be well-conducted in compliance with the protocol after approval by IEC/IRB. Any deviation or changes of the protocol shouldn’t be applied by the investigator without the sponsor’s agreement and documented approval/favorable opinion by IEC/IRB.

PRINCIPLE 7 – Informed Consent: A freely provided informed consent from each human subject before participation in any clinical trial should be obtained in compliance with the national culture(s) and requirements. The subjects should volunteer as informed participants. If giving informed consent is not possible for any subject, a legally authorized representative should give permission,by applicable law.

Principle 8 – Continuing Review/Ongoing Benefit-Risk Assessment: Clinical trials having humans as research subjects should be continued only if the benefit-risk assessment remains favorable. The sponsors should ensure a process to assess and evaluate the drug development continuously during the clinical trial. The ethics committee should conduct reviews during the research and monitor its progress.

Principle 9 – Investigator Qualifications: On behalf of the trial subjects, the decisions and medical care should be made by a qualified and duly licensed medical professional, i.e., physician or, when appropriate, a dentist.

Principle 10 – Staff Qualifications: Every individual who is involved in directing a trial must be qualified by training, education, and experience to perform their respective task. This includes the investigator and his/her supporting staff to assist him.

Principle 11 – Records: All the information during the clinical trial should be recorded, handled, and stored in a way to allows accuracy in its interpretation, reporting, maintenance, and verification.

Principle 12 –Confidentiality/Privacy: The confidentiality of records that could identify subjects must be protected, respecting the privacy and confidentiality rules in compliance with the applicable regulations This is done to safeguard the integrity of subjects.

Principle 13 – Good Manufacturing Practice (GMP): Manufacturing, handling, and storage of investigational product(s) should be in accordance with applicable GMP and should be used in accordance with the approved protocol.

Principle 14 – Quality Systems: Systems with procedures that assure the control assure and improve the quality of every aspect of the clinical trial must be implemented.

Turacoz Healthcare Solutions understands and abides by the GCP. We aim to deliver the best of the information about clinical research. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

If you have any queries, email us at [email protected].

References

  1. World Health Organization. Handbook for Good Clinical Research Practice (GCP), 2002. Available at https://www.fda.gov/files/medical%20devices/published/Presentation–Good-Clinical-Practice-101–An-Introduction-%28PDF-Version%29.pdf. As accessed Apr 14, 2020.
  2. Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1):e5.
  3. S. Food and Drug Administration. Good Clinical Practice 101: An Introduction. Available at https://www.fda.gov/files/medical%20devices/published/Presentation–Good-Clinical-Practice-101–An-Introduction-%28PDF-Version%29.pdf. As accessed Apr 14, 2020.
  4. Permissible Medical Experiments. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10: Nuremberg October 1946–April 1949. Washington: U.S. Government Printing Office (n.d.), 2,181-182.
  5. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979).
  6. International Organization for Standardization. ISO 14155:2011: Clinical investigation of medical devices for human subjects — Good clinical practice (2011). Available at https://www.iso.org/standard/45557.html.As accessed Apr 14, 2020.
  7. S. Food and Drug Administration: FDA Regulations Relating to Good Clinical Practice and Clinical Trials (2015). Available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-regulations-relating-good-clinical-practice-and-clinical-trials.As accessed Apr 14, 2020.

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